Testing different methods for setting ventilator support in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial aims to compare two strategies for setting pressure support ventilation (PSV) levels in mechanically ventilated patients with acute hypoxic respiratory failure. One strategy uses the traditional method based on tidal volume and respiratory rate, while the other utilizes the pressure muscle index to better match the patient's inspiratory effort. The study will be conducted in two ICU centers, with each method being tested for four weeks, separated by a washout period. The trial will also assess clinician adherence and explore clinical outcomes related to these ventilation strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. PSV initiated during the last 24 hours, whether transition from controlled modes or primary initiation;
2. Mechanical ventilation expected to be required for at least 24-48 hours by responsible physicians;
3. The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure \[PEEP\]);
4. No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4.

Exclusion Criteria:

1. Age younger than 18 years old;
2. Initiation of PSV before ICU admission;
3. Duration of mechanical ventilation longer than 7 days before enrollment;
4. History of neuromuscular diseases;
5. Clinical suspicion of increased intracranial pressure;
6. Presentation with pneumothorax and/or bronchopleural fistula;
7. Extracorporeal support;
8. Moribund conditions;
9. Refusal by the ICU physicians or the patient.

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jian-Xin Zhou, MD — Beijing Shijitan Hospital, Capital Medical University
• Study coordinator: Jian-Xin Zhou, MD
• Email: zhoujx.cn@icloud.com
• Phone: 8610 6392 6666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inspiratory-effort–targeted pressure support for adults on ventilators

  This study will test whether using inspiratory effort measured by the pressure muscle index to set pressure support helps adults with acute hypoxic respiratory failure on ventilators have better outcomes than the usual tidal volume and respiratory rate approach.

  Recruiting Capital Medical University · Beijing, Beijing Municipality · NCT06526598

• Computed inspiratory muscle pressure to monitor inspiratory effort during pressure-targeted assist/control ventilation

  This study tests a noninvasive computed pressure method (cPmus) to see if it matches the traditional esophageal pressure method for measuring inspiratory effort in adults on pressure-targeted ventilation with spontaneous breathing.

  Recruiting Capital Medical University · Beijing · NCT07886918

• Noninvasive estimate of inspiratory effort to monitor pressure support ventilation

  This study tests whether a noninvasive computed inspiratory muscle pressure (cPmus) can match the traditional esophageal pressure method for adults on pressure support ventilation.

  Recruiting Capital Medical University · Beijing · NCT07886892

• NIRS for EDResp: Which first helps hypoxemic adults best?

  This trial tests whether non-invasive ventilation with a mask (NIPPV) or high-flow nasal oxygen (HFNO) is more helpful for adults in the emergency department with acute hypoxemic respiratory failure.

  Recruiting at 9 sites Ohio State University · Tucson, Arizona and 8 other locations · NCT07558265

• Deciphering why some patients stay a long time in the ICU using detailed clinical profiling

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  Recruiting at 6 sites Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Lisbon, Lisbon District and 6 other locations · NCT07510776

• Delphi consensus to guide mechanical insufflation-exsufflation use in the ICU

  A panel of ICU and lung specialists will use a structured survey process to agree on best practices for using mechanical insufflation-exsufflation to help airway clearance in critically ill patients.

  Recruiting at 4 sites Medipol University · Naples and 3 other locations · NCT07420946

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.